BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY BONE SCREW

    MDR report key: 2882332 · Received December 20, 2012

    Report

    Report Number
    1818910-2012-28472
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    May 30, 2012
    Report Date
    December 7, 2012
    Manufacturer
    DEPUY WARSAW
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. C. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    **UPDATE** (B)(4) 2012 - PATIENT'S OPERATIVE RECORDS WERE RECEIVED. RECORDS INDICATE THE 52MM GRIPTION SHELL WAS AUGMENTED WITH A SINGLE CANCELLOUS SCREW. THE SCREW WAS ADDED TO THE PRODUCT PAGES AND THE COMPLAINT RE-OPENED. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE FOR THE UNKNOWN SCREW AS THE LOT CODES REQUIRED WERE NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. C. PATIENTS BIRTH DATE AND OPERATIVE NOTES WAS THE ONLY INFORMATION OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS INFECTION. (B)(6) 2012 - PATIENTS OPERATIVE RECORDS WERE RECEIVED. RECORDS INDICATE THE 52MM GRIPTION SHELL WAS AUGMENTED WITH A SINGLE CANCELLOUS SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY BONE SCREW SCREW KWA DEPUY WARSAW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention